As we head into what is anticipated to be a strong year for biopharma dealmaking, we look back at some of the biggest deals in 2025 that focus on biologics and biosimilars. Antibody Therapy Deals Novartis acquires Avidity Biosciences On October 26, 2025, Novartis AG and Avidity Biosciences, Inc. announced…
On November 17, 2025 Formycon AG (“Formycon”) announced development of a dupilumab biosimilar, FYB208, referencing Regeneron and Sanofi’s DUPIXENT. Dupilumab is a monoclonal antibody therapy designed to treat immunological disease by blocking interleukin 4 and interleukin 13 receptor signaling-induced type 2 inflammation. DUPIXENT is approved for the treatment of asthma,…
On November 3, 2025, Samsung Biologics announced the completion of the spin-off of its investment and subsidiary management business unit, and the establishment of Samsung Epis Holdings, an investment holding company that will oversee Samsung Bioepis and other future biotechnology subsidiaries. Samsung Biologics will continue to operate as a pure-play…
This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry”. This final guidance outlines the FDA’s “recommendations on the design and evaluation of comparative analytical…
On September 2, 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the FDA has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp) as denosumab biosimilars to Prolia® and XGEVA®, respectively. Both biosimilars have been approved for all indications of their reference products. BILDYOS® and BILPREVDA® are RANK ligand inhibitors used to treat…
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. (“Hikma”),…
Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development and commercial supply of the biosimilars, and Advanz responsible for registration and commercialization in Europe. Per the announcement, the agreement includes proposed…
Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. YUFLYMA is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. As we previously reported, Celltrion…
We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Janssen patents, and about Janssen seeking a preliminary injunction to block Amgen from the commercial manufacturing, sale, and offer for sale of its ustekinumab product. Briefing for the PI motion was…
The USPTO has proposed several fee changes for implementation in 2025. If implemented, these changes will increase filing fees for Inter Partes Reviews (IPRs) and Post Grant Reviews (PGRs) by 25% “to improve cost recovery.” Additionally, the PTO is proposing to allow IPR and PGR petitions to exceed the current…